Convex ostomy barrier and method of forming convex ostomy barriers of various softness

ABSTRACT

A convex ostomy barrier for attaching an ostomy appliance to a peristomal skin surrounding a stoma includes a skin barrier formed from a skin friendly adhesive, an inlet opening for receiving a stoma, and a convex insert system arranged adjacent the skin barrier to provide a convex body-side contour of the convex ostomy barrier. The convex insert system includes a convex insert and a ring, which are configured to be assembled together to form the convex insert system.

BACKGROUND

The following description generally relates to ostomy appliances, and inparticular, to an ostomy barrier.

Ostomy pouches for collecting bodily waste are used by individuals whohave had surgery such as a colostomy, ileostomy, or urostomy. Two commontypes of ostomy pouch systems are available, to wit, a one-piece pouchsystem and a two-piece pouch system. In a one-piece pouch system, anostomy barrier is permanently attached to a pouch. In such a one-piecepouch system, the entire pouch system including the ostomy barrier isremoved when a user wants to replace the pouch.

In a two-piece pouch system, a pouch and an ostomy barrier are providedas two separate devices. The two-piece pouch system typically includes apair of coupling rings, one of which is fixedly attached to the ostomybarrier, while the other is attached to the pouch. The coupling ringsare configured to mate with each other, such that the pouch may besecurely and removeably attached to the ostomy barrier by engaging thecoupling rings together. In use, the ostomy barrier is first attached toa user, and the pouch is secured to the faceplate by engaging thecoupling rings together. Thus, two-piece pouch systems allow a user toremove and replace a pouch without removing the ostomy barrier from theuser. This can help to reduce the discomfort and irritation associatedwith removing skin barrier adhesive from user's skin

Ostomy barriers are configured to seal against peristomal skin surfacesand protect the peristomal surfaces from exposure to stomal effluent.However, the topography of stomas and peristomal surfaces surroundingstomas varies among patients, and sealing an ostomy appliance againstsuch different peristomal surfaces and stomas remain as an area forfurther improvements. A person having a stoma that is flush or recessedmay find that applying external support or pressure from a barrier inthe peristomal region aids in directing the discharge of effluent fromthe stoma directly into the ostomy pouch. Accordingly, the effectivenessof an adhesive seal between the ostomy barrier and the peristomal skinsurface (i.e., a seal formed by the adhesive layer) may be prolonged.

The present disclosure provides an improved flexible convex barrier anda method of making convex barriers of various softness/hardnessaccording to various embodiments.

BRIEF SUMMARY

In one aspect, a convex ostomy barrier for attaching an ostomy applianceto a peristomal skin surrounding a stoma is provided. The convex ostomybarrier may include a skin barrier formed from a skin friendly adhesive,an inlet opening for receiving a stoma, and a convex insert systemarranged adjacent the skin barrier and configured to provide a convexbody-side contour of the convex ostomy barrier. The convex insert systemmay include a convex insert and a ring, which may be configured to beassembled together to form the convex insert system.

In an embodiment, the convex insert may include a core-out portionconfigured to receive the ring. In such an embodiment, the ring may bearranged in the core-out portion of the convex insert to form the convexinsert system having a convex ring-like body. The convex insert mayinclude an inner flange, a middle portion including the core-outportion, and an outer flange. The inner flange and the outer flange maybe connected by the middle portion and arranged in different axialplanes, wherein the convex insert system is configured to support theskin barrier on a body-side surface. In an embodiment, the convex insertmay include a radial wall radially extending from the outer flangetoward the inlet opening and an axial wall extending axially from theradial wall in a body-side direction, wherein the core-out portion isdefined by the radial wall and the axial wall on a body-side. The innerflange may extend from the axial wall toward the inlet opening, andwherein the outer flange, the middle portion, and the inner flangeprovides a step-like protrusion in the body-side direction.

In some embodiments, the convex ostomy barrier may be configured for atwo-piece ostomy pouch system comprising a flange including a couplingring. The flange may be attached to a pouch-side surface of the radialwall of the convex insert.

The convex ostomy barrier of any of the foregoing embodiments may beconfigured such that the convex ostomy barrier of varioussoftness/hardness may be provided by using different rings in the convexinsert system. For example, the convex ostomy barrier may be configuredto have a first softness/hardness by incorporating the convex insertsystem formed from the convex insert and the ring having a firstcharacteristic, or configured to have a second softness/hardnessdifferent than the first softness/hardness by incorporating the convexinsert system formed from the convex insert and the ring having a secondcharacteristic.

In another aspect, a method of making convex ostomy barriers of varioussoftness/hardness is provided. The method may include the step ofproviding a convex insert and a plurality of rings, wherein the convexinsert is configured to be assembled with one of the plurality of therings to form a convex insert system. Each of the rings may beconfigured to have a different characteristic to provide a differentsoftness/hardness when assembled with the convex insert and used in aconvex ostomy barrier. The method may also include the steps ofselecting one of the plurality of the rings according to a desiredsoftness/hardness of the convex ostomy barrier, assembling the convexinsert and the selected ring together to form the convex insert system,and attaching a skin barrier formed from a skin friendly adhesive to abody-side surface of the convex insert system.

In an embodiment, the plurality of the rings may include a first ringhaving a first characteristic and a second ring having a secondcharacteristic. The convex insert may be assembled with the first ringto form a first convex insert system for a first convex ostomy barrier,or the convex insert may be assembled with the second ring to form asecond convex insert system for a second convex ostomy barrier, whereinthe first convex ostomy barrier has a first softness/hardness and thesecond convex ostomy barrier has a second softness/hardness that isdifferent than the first softness/hardness.

In some embodiments, the step of providing a convex insert and pluralityof rings may include the step of providing the convex insert including acore-out portion configured to receive one of the plurality of rings. Insuch embodiments, the step of assembling the convex insert and theselected ring may comprise arranging the selected ring in the core-outportion of the convex insert to form the convex insert system having aconvex ring-like body. The convex insert may include an inner flange, amiddle portion including the core-out portion, and an outer flange,wherein the inner flange and the outer flange are connected by themiddle portion and arranged in different axial planes. The convex insertsystem may be configured to support the skin barrier on a body-sidesurface.

In an embodiment, the convex insert may include a radial wall radiallyextending from the outer flange toward the inlet opening and an axialwall extending axially from the radial wall in a body-side direction,wherein the core-out portion is defined by the radial wall and the axialwall on a body-side. The inner flange may extend from the axial walltoward the inlet opening, wherein the outer flange, the middle portion,and the inner flange provide a step-like protrusion in the body-sidedirection.

The method of any of the foregoing embodiments may further include thestep of providing a flange including a coupling ring, wherein the flangeis attached to a pouch-side surface of the radial wall of the convexinsert.

Other aspects, objectives and advantages will become more apparent fromthe following detailed description when taken in conjunction with theaccompanying drawings.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

The benefits and advantages of the present embodiments will become morereadily apparent to those of ordinary skill in the relevant art afterreviewing the following detailed description and accompanying drawings,wherein:

FIG. 1 is a perspective view of a convex ostomy barrier including aconvex insert system according to an embodiment with a portion removedto illustrate its layered structure;

FIG. 2 is a perspective view of a convex insert system including aconvex insert and a ring according to an embodiment;

FIG. 3 is a schematic top view of the convex insert system of FIG. 2;

FIGS. 4A and 4B are schematic cross sectional views of the convex insertsystem of FIG. 3 taken along 4-4;

FIG. 5 is a schematic cross sectional view of the convex insert systemof FIGS. 4A and 4B showing the ring received in the convex insert;

FIG. 6 is a perspective view of a convex insert and a plurality of ringsaccording to an embodiment; and

FIG. 7 is a perspective view of one of the rings of FIG. 6.

DETAILED DESCRIPTION

While the present disclosure is susceptible of embodiment in variousforms, there is shown in the drawings and will hereinafter be describeda presently preferred embodiment with the understanding that the presentdisclosure is to be considered an exemplification and is not intended tolimit the disclosure to the specific embodiment illustrated.

Referring to FIG. 1, a convex ostomy barrier 10 according to anembodiment is shown with a portion removed and viewed from a pouch-sideto illustrate a layered construction of the convex ostomy barrier 10.The convex ostomy barrier 10 may be configured for a two-piece pouchsystem, and may generally comprise a skin barrier 12, a flange 16, aconvex insert system 18, release liners 24, 26, and an inlet opening 28for receiving a stoma.

FIGS. 2-5 are illustrations of the convex insert system 18 including aconvex insert 19 and a ring 21 according to an embodiment. The convexinsert 19 and the ring 21 may be configured to be assembled together toform the convex insert system 18 having a convex ring-like shaped body.The convex insert system 18 may be configured to provide the convexityof the convex ostomy barrier 10 to apply pressure around the peristomalarea when the convex ostomy barrier 10 is attached to a user.

The softness/hardness of the convex ostomy system 18 may be determinedby the combined softness/hardness of the convex insert 19 and the ring21. As such, the softness/hardness of the convex ostomy system 18 may beeasily altered or controlled by incorporating a ring 21 having adifferent softness/hardness. Such a feature may provide significant costsavings since convex ostomy barriers 10 of various convexityhardness/softness may be manufactured by making and incorporating rings21 of various softness/hardness, instead of making convex inserts ofvarious softness/hardness.

In FIG. 6, the convex insert 19 is illustrated with three rings 21, 21′,21″. Each of the rings 21, 21′, 21″ may be configured to have adifferent softness/hardness. As such, a convex insert system prepared byassembling the convex insert 19 and the ring 21 may provide a firstsoftness/hardness, and a convex insert system prepared by assembling theconvex insert 19 and the ring 21′ may provide a second softness/hardnessthat is different from the first softness/hardness, and a convex insertsystem prepared by assembling the convex insert 19 and the ring 21″ mayprovide a third softness/hardness that is different from the first orsecond softness/hardness.

The convex insert 19 may be configured to protrude axially toward abody-side direction and configured to receive the ring 21 as shown inFIGS. 2-5. The convex insert 19 may include an outer flange 40, a middleportion 42, and an inner flange 44, and a radial wall 60 providing agenerally flat pouch-side surface 64 on a pouch-side of the convexinsert 19 for attachment of the flange 16. The outer flange 40 mayinclude a concave body-side surface 50, which is configured to conformto a curved contour of a lower base portion 20 of a convex portion ofthe skin barrier 12. The radial wall 60 including the pouch-side surface64 may be arranged in the middle portion 42. The middle portion 42 alsomay include a core-out portion 54 configured to receive the ring 21. Thecore-out portion 54 may be defined by the radial wall 60, which mayradially extend from the outer flange 40 toward the inlet opening 28,and an axial wall 62, which may axially extend from the radial wall 60toward a body-side direction. The inner flange 44 may radially extendfrom the axial wall 62 toward the inlet opening 28. The middle portion42 may be configured to provide a step-like axial protrusion in thebody-side direction from the outer flange 40 to the inner flange 44.

The ring 21 may have a relatively thin ring-like body as shown in FIGS.6 and 7. The ring 21 may be configured such that the pouch-side of thering 21 may fit in the core-out portion 54 of the convex insert 19 asbest shown in FIGS. 4B60

and 5. In an embodiment, the ring 21 may include a radial pouch-sidesurface 70 and an axial pouch-side surface 72, and a sloped body-sidesurface 74. When received in the core-out portion 54 of the convexinsert 19, the radial pouch-side surface 70 may be arranged adjacent theradial wall 60 of the convex insert 19 and the axial pouch-side surface72 may be arranged adjacent the axial wall 72 of the convex insert 19.In such an embodiment, the body-side surface of the inner flange 44 ofthe convex insert 19, the sloped body-side surface 74 of the ring 21,and the body-side surface of the outer flange 49 of the convex insert 19may form a generally continuous body-side surface of the convex insertsystem 18 as shown in FIG. 5.

The convex insert 19 and the ring 21 may be formed from the same ordifferent materials. Suitable materials for the convex insert 19 and thering 21 may include, but are not limited to, polymeric materials,rubber, silicone, and metallic materials. For example, the convex insert19 and the ring 21 may be formed from a heat sealable thermoplasticmaterial, such as ethylene vinyl acetate (EVA), thermoplastic elastomer,or thermoplastic urethane. In another example, the convex insert 19 andthe ring 21 may be formed from a foam or silicone.

In FIG. 1, the convex insert system 18 is used in the convex ostomybarrier 10 for a two-piece pouch system, which may include the flange 16having a body-side coupling ring 22 for attaching an ostomy pouch. Inother embodiments, the convex insert system 18 including the convexinsert 19 and the ring 21 may be used in a convex ostomy barrier for aone-piece pouch system. The body-side coupling ring 22 may be configuredto mate with a pouch-side coupling ring (not shown), such that theostomy pouch may be mechanically secured to the ostomy barrier 10 whenthe coupling rings are engaged with each other. The flange 16 may beattached to the convex insert 19 via a flange film 30. In the embodimentof FIG. 1, the flange 16 is attached to a pouch-side surface of theflange film 30 proximate an outer periphery of the flange film 30. Theconvex insert 19 may be attached to a body-side surface of the flangefilm 30 proximate an inner peripheral portion of the flange film 30,such that the flange 16 and the convex insert 19 are attached on theopposite surfaces of the flange film 30 at opposite ends. Such aconfiguration provides a floating flange feature, in which a user mayinsert his/her finger between the flange 16 and the convex insert 19 tofacilitate engagement of the coupling rings to attach a pouch to theostomy barrier 10.

The skin barrier 12 may be arranged on the body-side surface of theostomy barrier 10 for attachment to a user. The inlet opening 28 may bedefined by an inner periphery of the skin barrier 12 for receiving astoma (not shown.) The skin barrier 12 may be formed from a suitablemedical-grade adhesive that can adhesively secure the ostomy barrier 10to a patient's skin in the peristomal region, such as a hydrocolloidadhesive composition.

The ostomy barrier 10 may also include a tape 14 including an adhesivelayer 32 and a backing layer 34. In some embodiments, the skin barrier12 may include a backing layer 36 laminated on the pouch-side surface ofthe skin barrier 12. The backing layer 36 may be formed from a suitableheat sealable polymeric material, such that the backing layer 36 may beheat sealed to the tape 14.

In the embodiment of FIG. 1, the skin barrier 12 is attached to aportion of the adhesive layer 32 proximate the inlet opening 28 with thebacking layer 36 therebetween. In such an embodiment, an outerperipheral portion of the adhesive layer 32 may be attached to a usersurrounding the skin barrier 12 to provide additional security.

The adhesive layer 32 of the tape 14 may be formed from a suitablemedical adhesive, such as an acrylic adhesive. The backing layer 34 maybe formed from a suitable material, such as a nonwoven material or athin polymeric film.

In other embodiments, the ostomy barrier 10 may not include the tape 14.In such an embodiment, the skin barrier 12 may be the only means forattaching the ostomy barrier 10 to a user.

In the embodiment of FIG. 1, the convex insert system 18 may be attachedto the backing layer 34 of the tape 14 to provide a convexity to theskin barrier 12. In other embodiments, the convex insert system 18 maybe attached to a pouch-side surface of the skin barrier 12.

In the embodiment of FIG. 1, the flange film 30 may be attached to thepouch-side surface 64 of the convex insert 19 to secure the flange 16.For example, the flange film 30 may be heat sealed to the pouch-sidesurface 64 of the convex insert 19. As shown in FIG. 1, the body-sidesurfaces of the outer flange 40 of the convex insert 19, the slopedbody-side surface 74 of the ring 21, and the body-side surface of theinner flange 44 of the convex insert 19 may be in contact with the tape14, wherein at least some portions of which are attached to the backinglayer 34. For example, the body-side surface of the outer flange 40 maybe heat sealed to the backing layer 34 of the tape 14. In anotherexample, an adhesive may be provided on the body-side surface of theconvex insert system 18 for attachment to the tape 14.

A release liner may be provided to cover the skin barrier 12 and thetape 14. In the embodiment of FIG. 1, the release liner 24 is providedto cover an outer peripheral portion of the tape 14, and the releaseliner 26 is provided to cover the entire body-side surface of the ostomybarrier 10 including the skin barrier 12 and the tape 14. In use, therelease liner 26 may be removed first for attachment of the skin barrier12 to peristomal skin, and the release liner 24 may be removedsubsequently to expose the tape 14 for further attachment to user'sskin.

All patents referred to herein, are hereby incorporated herein in theirentirety, by reference, whether or not specifically indicated as suchwithin the text of this disclosure.

In the present disclosure, the words “a” or “an” are to be taken toinclude both the singular and the plural. Conversely, any reference toplural items shall, where appropriate, include the singular.

From the foregoing it will be observed that numerous modifications andvariations can be effectuated without departing from the true spirit andscope of the novel concepts of the present invention. It is to beunderstood that no limitation with respect to the specific embodimentsillustrated is intended or should be inferred. The disclosure isintended to cover by the appended claims all such modifications as fallwithin the scope of the claims.

1. A convex ostomy barrier for attaching an ostomy appliance to aperistomal skin surrounding a stoma, the convex ostomy barriercomprising: a skin barrier formed from a skin friendly adhesive; aninlet opening for receiving a stoma; and a convex insert system arrangedadjacent the skin barrier and configured to provide a convex body-sidecontour of the convex ostomy barrier, wherein the convex insert systemincludes a convex insert and a ring, wherein the convex insert and thering are configured to be assembled together to form the convex insertsystem.
 2. The convex ostomy barrier of claim 1, wherein the convexinsert includes a core-out portion configured to receive the ring,wherein the ring is arranged in the core-out portion of the convexinsert to form the convex insert system having a convex ring-like body.3. The convex ostomy barrier of claim 2, wherein the convex insertcomprises an inner flange, a middle portion including the core-outportion, and an outer flange, wherein the inner flange and the outerflange are connected by the middle portion and arranged in differentaxial planes, wherein the convex insert system is configured to supportthe skin barrier on a body-side surface.
 4. The convex ostomy barrier ofclaim 3, wherein the convex insert includes a radial wall radiallyextending from the outer flange toward the inlet opening, and an axialwall extending axially from the radial wall in a body-side direction,wherein the core-out portion is defined by the radial wall and the axialwall on a body-side, wherein the inner flange extends from the axialwall toward the inlet opening, and wherein the outer flange, the middleportion, and the inner flange provides a step-like protrusion in thebody-side direction.
 5. The convex ostomy barrier of claim 1, furthercomprising a flange including a coupling ring, wherein the flange isattached to a pouch-side surface of the radial wall of the convexinsert.
 6. The convex ostomy barrier of claim 1, wherein the convexostomy barrier is configured to have a first softness/hardnesscomprising the convex insert system formed from the convex insert andthe ring having a first characteristic, wherein the convex ostomybarrier is configured to have a second soflness/hardness comprising theconvex insert system formed from the convex insert and the ring having asecond characteristic; wherein the first softness/hardness is differentfrom the second softness/hardness and the first characteristic isdifferent from the second characteristic.
 7. A method of making convexostomy barriers of various softness/hardness, comprising the steps of:providing a convex insert and a plurality of rings, wherein the convexinsert is configured to be assembled with one of the plurality of therings to form a convex insert system, wherein each of the rings has adifferent characteristic; selecting one of the plurality of the ringsaccording to a desired hardness/softness of a convex ostomy barrier;assembling the convex insert and the selected ring together to form theconvex insert system; and attaching a skin barrier to a body-sidesurface of the convex insert system; wherein the skin barrier is formedfrom a skin friendly adhesive.
 8. The method of claim 7, wherein theplurality of the rings includes a first ring having a firstcharacteristic, a second ring having a second characteristic, whereinthe convex insert is assembled with the first ring to form a firstconvex insert system for a first convex ostomy barrier; wherein theconvex insert is assembled with the second ring to form a second convexinsert system for a second convex ostomy barrier; wherein the firstconvex ostomy barrier has a first softness/hardness, and the secondconvex ostomy barrier has a second softness/hardness, wherein the firstsoflness/hardness is different than the second softness/hardness.
 9. Themethod of claim 1, wherein the step of providing a convex insert andplurality of rings comprises providing the convex insert including acore-out portion configured to receive one of the plurality of rings,wherein the step of assembling the convex insert and the selected ringcomprises arranging the selected ring in the core-out portion of theconvex insert to form the convex insert system having a convex ring-likebody.
 10. The method of claim 9, wherein the convex insert comprises aninner flange, a middle portion including the core-out portion, and anouter flange, wherein the inner flange and the outer flange areconnected by the middle portion and arranged in different axial planes,wherein the convex insert system is configured to support the skinbarrier on a body-side surface.
 11. The method of claim 10, wherein theconvex insert includes a radial wall radially extending from the outerflange toward the inlet opening, and an axial wall extending axiallyfrom the radial wall in a body-side direction, wherein the core-outportion is defined by the radial wall and the axial wall on a body-side,wherein the inner flange extends from the axial wall toward the inletopening, and wherein the outer flange, the middle portion, and the innerflange provide a step-like protrusion in the body-side direction. 12.The method of claim 11, further comprising the step of providing aflange including a coupling ring, wherein the flange is attached to apouch-side surface of the radial wall of the convex insert.